A review of the literature on the new European Medical Device Regulations requirements for increased clinical evaluation

Purpose: The European Union (EU) Medical Device Regulations (MDR) 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study aims to investigate the impact of these strengthened requirements on medical device manufacturers by investigating the challenges they encounter while generating an MDR-compliant clinical evaluation report. Design/methodology/approach: A systematic literature review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses method of peer-reviewed literature and various government jurisdictional reports and legislation. Findings: The findings from the study understanding what constitutes sufficient clinical evidence poses the biggest challenge to the generation of an MDR-compliant clinical evaluation report. Resulting from the challenges they are facing, manufacturers of certain CE-marked medical devices are planning to remove (and have removed) devices from the EU market upon expiration of their certificate, and in the case of new and innovative devices, some manufacturers are planning to launch in other markets ahead of the EU. These challenges will lead to a potential shortage of certain medical devices in the EU and a delay in access to new devices, thereby negatively impacting patients’ quality of life. Practical implications: This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the EU. A limitation is the lack of literature analysing the regulations and their effects. Originality/value: This study has both theoretical contributions in that, to the best of the authors’ knowledge, it is the first detailed and systematic review of the new MDR Regulations and has implications for practice as manufacturers and policymakers can leverage it alike to understand the challenges of the new MDR.